Infections represent one of the most common complications of childbirth. Even in developed countries, individual cases and epidemics of cord infections continue to occur such as in births outside of hospital settings. In developing nations where health care infrastructure is commonly limited, most deliveries occur outside a hospital setting with help from family or birth attendants. Two-thirds of neonatal deaths worldwide occur in developing countries, where traditional birth practices involve severing the cord using non-sterile instruments that often lead to infection. This is due not only to poor access to healthcare but also socio-cultural behaviors. In many cultures, some type of ritual substance is applied to the cord stump. Ash, oil, butter, spice pastes, herbs, mud, and cow or chicken dung are commonly used, and they are often contaminated with bacteria and spores. This practice of applying substances to the cord is most commonly employed to prevent bleeding, to promote separation of the stump, and to keep spirits away. With such unsanitary conditions, there exists a much higher rate of infant mortality due to preventable causes, such as bacterial infections and neonatal tetanus. The lack of research efforts targeted at birth conditions outside of hospitals in developing nations has simultaneously prevented the development of effective, affordable, and feasible preventative strategies that could be widely applied towards neonatal health.
The first few weeks of a newborn mammal's life are critical to its long-term survival and health. Umbilical cord care is just as important in veterinary use as it is in human use, especially since the environment an animal is born into is usually less sterile than that of a human birth. The umbilical cord is usually severed immediately after a birth, and typically a disinfectant is applied to prevent pathogens from entering an animal's body through the cord. Umbilical cord devices are rarely used in veterinary medicine, even though they could be equally as beneficial in helping to prevent infection. Large animal births, in particular, could benefit from an improved means of severing, disinfecting, and covering the umbilical cord, as many large animal births are not attended by a trained veterinarian but by a livestock handler.
Currently, there is limited support for research that focuses on the preventable causes of neonatal infection and death. A key disadvantage of the present umbilical cord cutting method is its multi-step nature; the procedure of severing the umbilical cord involves three pieces of equipment: two clamps and a cutter. In practice, two metal clamps are secured to the umbilical cord in a spaced relation to one another, and the cord is then cut between the two clamps using scissors. The metal clamp on the baby's side is then replaced with a plastic clamp and the other is removed when the placenta is discarded. Outside of the hospital, the method for severing the umbilical cord often involves the use of tying devices, usually a type of string, to stop the flow of blood and a sharp blade, often contaminated, to sever the cord between the two points. Additionally, cutting the cord at an intermediate distance between two clamps leaves an edge of the cord past the clamp, which is a prime site for infection.
Various surgical instruments have been developed to separate and clamp the umbilical cord joining a newborn infant and the mother. However, most are reusable, which presents additional health concerns due to the possibility of contamination and infection; those that claim not to be reusable still utilize a metallic cutting device that could be easily removed and reused. The metallic blade is problematic for three reasons: it is a safety hazard, there is a risk of the blade being removed for reuse, and it is less economical to manufacture and distribute. In addition, variations on obstetric scissors do not provide adequate protection from blood splatter, placing the birth attendant at risk from contracting Hepatitis B, Hepatitis C, and HIV. Furthermore, it is usually necessary to first orient the device so that the clamp side with the blade remains on the mother's side of the cord to be discarded with the placenta. Improper orientation of such devices is more likely to occur in developing nations because language barriers will limit the effectiveness of providing instructions for proper use. This type of mistake may leave the wrong side of the device with the newborn, possibly resulting in infection and various other complications.
Some umbilical clamps include two parts, a maternal-side clamp and an infant-side clamp which are aligned and joined during the clamping procedure and separated after the clamping procedure. U.S. patent application Ser. No. 12/506,799 describes such a device and is hereby incorporated by reference in its entirety.
While certain novel features of this invention shown and described below are pointed out in the claims, the invention is not intended to be limited to the details specified, since a person of ordinary skill in the relevant art will understand that various omissions, modifications, substitutions and changes in the forms and details of the invention illustrated and in its operation may be made without departing in any way from the spirit of the present invention. No feature of the invention is critical or essential unless it is expressly stated as being “critical” or “essential.”